PolarityTE Appoints Richard Hague as Chief Executive Officer and Elects David Seaburg to Board of Directors and Chair of Strategic Review Committee
September 02 2021 - 8:00AM
Business Wire
Ryan Mathis, MD, named Chief Medical
Officer
PolarityTE, Inc. (Nasdaq: PTE) today announced the
appointment of Richard Hague as Chief Executive Officer, the
election of David Seaburg to the Board of Directors, and the
appointment of Ryan Mathis, MD, as Chief Medical Officer.
Mr. Hague joined the Company in April 2019 as Chief Operating
Officer and served in the Office of the Chief Executive beginning
in August 2019 until April 2020, when he began serving as the
Company’s President in addition to Chief Operating Officer. Mr.
Hague is an accomplished biotechnology executive with extensive
experience across multiple disciplines in companies at various
stages of product development and commercialization. Before joining
PolarityTE, Mr. Hague was the Chief Commercial Officer at Anika
Therapeutics, where he oversaw all global commercial activities, as
well as the R&D and Clinical Research functions. Prior to his
tenure with Anika, Mr. Hague was Vice President of Sales and
Marketing at TEI Medical, where he led the significant sales growth
of their wound care product platform, which was later acquired by
Integra LifeSciences. He spent a significant portion of his career
at Genzyme and later Sanofi (following Sanofi’s acquisition of
Genzyme), where he held positions of increasing responsibility,
culminating in his role as VP/General Manager of Sanofi’s Cell
Therapy and Regenerative Medicine Business Unit. While at Genzyme,
Mr. Hague was involved in the launch of the first autologous cell
therapy product that ultimately led to FDA’s establishment of the
BLA regulatory pathway. Subsequently, he has led the successful
development and launch of several innovative products in the
biologics and medical device arenas.
With PolarityTE’s transition away from a commercial enterprise
and towards a clinical research and development stage company, the
Board is pleased to have Mr. Seaburg rejoin as a director and looks
forward to his continued support of the Company, management team,
and strategic initiatives. Mr. Seaburg will become the Chair of the
Board’s Strategic Review Committee and is expected to participate
in the Company’s corporate strategy and capital formation
activities.
Mr. Seaburg joined PolarityTE in August 2018 as a director and
subsequently joined the management team in January 2019, serving as
President of Corporate Development until August 2019, when he
joined the Office of the Chief Executive, before being named Chief
Executive Officer in April 2020. During Mr. Seaburg’s tenure in
management, the Company completed several significant restructuring
initiatives, primarily focused on reducing costs, enhancing sales
of SkinTE® when it was previously marketed as a 361 HCT/P, and
preparing PolarityTE for the changes that would be required from a
regulatory perspective for SkinTE following the conclusion of FDA’s
period of enforcement discretion for 361 HCT/Ps in May 2021. Under
Mr. Seaburg’s leadership, the Company substantially reduced its
operating costs, grew revenues to record levels when SkinTE was
marketed, and Mr. Seaburg was instrumental in shifting the
Company’s strategic focus to pursuing a biologics license
application for SkinTE. In the fourth quarter of 2019, just after
Mr. Seaburg joined management, revenues from the sale of SkinTE
were $0.7 million, and in the first quarter of 2021, which was the
last full quarter of SkinTE sales activity, the Company’s revenues
for SkinTE were $1.73 million or 147% higher. Furthermore, cash
used in operations during the fourth quarter of 2019 was $16.0
million, or an average of $5.3 million per month, and in the second
quarter of 2021 cash used in operations was $4.1 million, or an
average of $1.4 million per month—a difference of 74%.
Dr. Mathis has been with the Company since December 2017,
serving in roles of increasing responsibility including Vice
President of Clinical Operations and, most recently, Vice President
of Commercial Strategy. In that role, Dr. Mathis led important
changes to the SkinTE commercial function when the product was
previously marketed as a 361 HCT/P. Dr. Mathis earned his
undergraduate and medical degrees at Penn State University before
joining the Medstar Georgetown University Plastic Surgery
Department as a resident. While at Georgetown, Dr. Mathis received
numerous awards from his peers and colleagues for distinguished
clinical performance and for medical education. Dr. Mathis has
published multiple papers and presented on various clinical and
basic science research topics in the fields of plastic surgery,
cardiac surgery, and wound care, and is a visiting Professor for
the Biotechnology Program at Georgetown University.
David Seaburg commented, “With the changes we implemented over
the past two years and the clear strategic focus we have achieved,
now is the appropriate time for me to rejoin the Board of
Directors. The Company is in great hands with Richard Hague at the
helm, and Rich’s extensive industry experience will be vital as we
progress SkinTE down the BLA regulatory pathway. We are fortunate
to have a clinical leader in Ryan Mathis who spent years on the
front lines and saw the extraordinary clinical impact that SkinTE
had on patients, while also collecting invaluable feedback from
physicians and other healthcare providers in the field.”
Richard Hague commented, “Nothing drives me more than helping to
bring groundbreaking treatments to patients in need. Having seen
the evolution of the BLA pathway first-hand during my time at
Genzyme, I could not be more excited to lead PolarityTE as we seek
to commence clinical studies with SkinTE under IND and advance this
extraordinary asset towards a BLA submission. We have been working
closely with the FDA and look forward to crafting a development
program for SkinTE to maximize its clinical reach in service of
patients suffering from hard-to-treat chronic cutaneous ulcers. The
experience we gained during the prior marketing of SkinTE as a 361
HCT/P gives me and our team tremendous confidence moving forward.
We have a great deal of work to do but are energized and emboldened
to do whatever it takes to make this product available to patients
once again. I want to thank David for his leadership and execution
over the past two years and I look forward to continuing to work
with him in his new role on the Board.”
About PolarityTE®
PolarityTE is focused on transforming the lives of patients by
discovering, designing, and developing a range of regenerative
tissue products and biomaterials for the fields of medicine,
biomedical engineering and material sciences. Rather than
manufacturing with synthetic and foreign materials within
artificially engineered environments, PolarityTE manufactures
products from the patient's own tissue and uses the patient's own
body to support the regenerative process. From a small piece of
healthy autologous tissue, the company creates an easily
deployable, dynamic, and self-propagating product designed to
regenerate the target tissues. PolarityTE's innovative methods are
intended to promote and accelerate growth of the patient's tissues
to undergo a form of effective regenerative healing. PolarityTE’s
products, including SkinTE, are in the development stage, and are
not approved or available for clinical use. Learn more at
www.PolarityTE.com – Welcome to the Shift®.
Forward Looking Statements
Certain statements contained in this release are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. They are generally
identified by words such as "believes," "may," "expects,"
"anticipates," "intend," "plan," "will," "would," "should" and
similar expressions. Readers should not place undue reliance on
such forward-looking statements, which are based upon the Company's
beliefs and assumptions as of the date of this release. The
Company's actual results could differ materially due to the impact
of the COVID-19 pandemic, future clinical studies, and FDA
regulatory matters, which cannot be predicted, and the risk factors
and other items described in more detail in the "Risk Factors"
section of the Company's Annual Reports and other filings with the
SEC (copies of which may be obtained at www.sec.gov). Subsequent
events and developments may cause these forward-looking statements
to change. The Company specifically disclaims any obligation or
intention to update or revise these forward-looking statements as a
result of changed events or circumstances that occur after the date
of this release, except as required by applicable law.
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are registered trademarks of
PolarityTE, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210902005133/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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